TGA Publishes More Information About Medicine Formulations

To improve access to important medicine information, the Therapeutic Goods Administration (TGA) now publishes additional formulation details of medicines and biological products on its website. This means anyone can check the ingredients contained in medicines, helping people make better-informed choices about the products they use. Every therapeutic good approved for supply in Australia has an ARTG summary on the TGA website. Previously, these summaries only showed information about active ingredients, which are the ingredients responsible for a product's medicinal effect. ARTG summaries for all medicines and biologicals now list both the active ingredients and non-active (excipient) ingredients. You will be able to see if a product contains a flavour, fragrance or colour ingredient mix, but not the individual ingredients in that mix. These medicines and biologicals have not changed - instead the TGA is increasing the transparency of this information to help consumers in their discussions with their health professionals.    Source: Ingredient transparency

Disinfectants for Use Against COVID-19 in the ARTG for Legal Supply in Australia

The TGA has recently received a number of enquiries seeking to know which disinfectants have been entered into the Australian Register of Therapeutic Goods (ARTG) for use against COVID-19. Claims that a disinfectant has an effect against any virus must be expressly permitted by the TGA before being used in consumer advertising (including on the label). In response to the COVID-19 pandemic, the TGA has permitted SARS-CoV-2 and COVID-19 virus claims. The full list is comprised of disinfectant products that have been entered into the ARTG with specific claims against SARS-Cov-2 (COVID 19) or COVID-19 on the product label and can be read here:   Source: Covid-19 disinfectants    

Western Australian Fined for Alleged Breaches In Relation To COVID-19 Test Kits

The TGA has issued a $2,250 infringement notice to a woman in Western Australia for alleged breaches of the Therapeutic Goods Act 1989 (the Act). The woman allegedly breached a condition of the Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020  by importing COVID-19 test kits that were not included in the Australian Register of Therapeutic Goods (ARTG) and were not being imported in relation to an authorised pathology laboratory as required by the Exemption.   Source: Covid19 - test kit fine

Promedical Equipment Fined $63,000 for Alleged Unlawful Advertising of a COVID-19 Rapid Test Kit

The TGA has issued five infringement notices totalling $63,000 to Queensland company Promedical Equipment Pty Ltd. It is alleged that the company claimed or implied on its website and via social media that the TGA and the United States Food and Drug Administration (FDA) had endorsed or approved a COVID-19 Rapid Test kit. Advertisements for therapeutic goods must not make any statement that implies the goods have been recommended or approved by government, except in very limited circumstances. This includes statements that therapeutic goods have been approved by the TGA or international regulators such as the FDA.   Source: Covid19 test-kit fail  (Please also see related stories: Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG ; COVID-19 test kits included in the ARTG for legal supply in Australia)

Company Issued $12,600 Infringement Notice for Alleged COVID-19 Advertising Breach

Melbourne based company NutriPATH Pty Ltd has been issued with a $12,600 fine for the alleged unlawful advertising of a COVID-19 Polymerase Chain Reaction (PCR) test collection kit in breach of the Therapeutic Goods Act 1989 (the Act).   Source: False advertising penalty

Doctor Fined $37,800 for Alleged Advertising Breaches Including References to COVID-19

A doctor in Perth, has been fined $37,800 for alleged unlawful advertising of therapeutic goods in relation to COVID-19 on his website.   Source: Covid19 advertising breech

TGA Q & A: End of Advertising Pre-Approval Scheme

Up until 1 July 2020, advertisements for 'designated therapeutic goods' that are to appear in 'specified media' require approval under the Therapeutic Goods Regulations 1990 before they can be published or broadcast. The TGA outsourced the processing of applications for advertising approval to Consumer Healthcare Products Australia until 30 June 2020. This advertising pre-approval scheme will be stopped in favour of a more self-regulatory regime. This Q & A fact sheet will assist all advertisers of ‘designated therapeutic goods’ to comply with the new regulations.   Source: Advertising therapeutic goods  (Please see also further reading: End of pre-approval process for ads in specified media )

Do you need your advertisement checked?

RFA Regulatory Affairs has decades of experience advising clients on complying with advertising code requirements – for complementary medicines, foods and cosmetics. We also offer training in all these areas, refer to our website Training Courses or contact Kate Durey  This email address is being protected from spambots. You need JavaScript enabled to view it. for more information.

TGA Safety Advisory - Andrographis paniculata

Andrographis is a herb commonly used in Indian and Chinese medicine and is known as the 'King of bitters'. Consumers and health professionals are advised that products containing the herb Andrographis paniculata may be associated with changes in the sense of taste (also known as taste disturbance), including complete loss of taste.    Source: Safety advisory - Andrographis

TGA Social Media Advertising Guide

Advertising therapeutic goods in social media poses unique challenges. This guide is designed to help advertisers apply the legislative requirements for advertising therapeutic goods on social media platforms. Not all information about therapeutic goods is advertising; however, the definition of 'advertise' in relation to therapeutic goods is broad. Any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods is an advertisement. A social media post that promotes the use or supply of therapeutic goods is an advertisement. Whether an advertisement for therapeutic goods appears on social media or in any other media, the advertisement must comply with therapeutic goods legislation.   Source: Social media advertising

Guide to Using Scientific or Clinical Claims (Representations) in Therapeutic Goods Advertising

It is important to understand how to correctly use scientific or clinical claims when advertising therapeutic goods to the public. This information is for those involved in the marketing of therapeutic goods who use scientific or clinical representations or claims in advertisements by: using scientifically framed claims (i.e. scientific claims); citing research studies (explicitly or impliedly), or, using scientific (and pseudoscientific) terminology. A 'scientific' or 'clinical' representation is one that: uses scientific or medical terminology that is not generally used in the everyday language of the audience to whom the advertisement is directed, or necessarily and overtly relies on scientific or clinical research (such as 'clinically demonstrated to ...' or 'studies show...'). Compliant scientific claims are just the first step to a compliant advertisement. Remember to ensure that your advertising complies with the other applicable requirements in the Therapeutic Goods Act 1989 and the Code.   Source: Scientific or clinical references

TGA Webinar: Supplying and Advertising Therapeutic Goods for COVID-19: Information for New Sponsors

If you are looking to import, supply, manufacture, export or advertise a product to help test for, prevent or treat COVID-19, you are a potential sponsor of a therapeutic good and need to meet certain requirements under the Therapeutic Goods Act 1989. This webinar assists new and potential sponsors of therapeutic goods to meet their regulatory and legislative obligations in relation to COVID-19, and will include an interactive question and answer session with TGA staff. It covers the basics of therapeutic goods regulation with a focus on hand sanitisers, disinfectants, personal protective equipment and advertising. This webinar will be held on Thursday, 28 May 2020, 12:30pm-3:30pm AEST.   Source: Covid-19 webinar

Hand Sanitisers: Information for Manufacturers, Suppliers and Advertisers

This information is intended to help manufacturers, suppliers and advertisers of hand sanitisers to understand their regulatory obligations under therapeutic goods legislation. Specifically, this information covers: hand sanitisers that are excluded from TGA regulation because they meet specified formulation, manufacturing, labelling and advertising requirements; hand sanitisers that are excluded from TGA regulation because they are cosmetics; hand sanitisers that are regulated as therapeutic goods by the TGA; and, advertising requirements for hand sanitisers. Hand sanitisers that are regulated as therapeutic goods must be approved by the TGA before they are supplied, while hand sanitisers that are excluded from TGA regulation (either because they meet the specified requirements or because they are cosmetics) do not require TGA approval before they are supplied. All hand sanitisers are subject to advertising requirements.   Source: Hand sanitisers   (Please see also related legislation: Legislation: hand sanitisers 2020 and Sanitiser info for consumers  ).

Notice of Final Decisions to Amend the Current Poisons Standard – Caffeine

The TGA has made a final decision to affirm the interim decision and amend the current Poisons Standard in relation to caffeine. The decision will take effect on 1 June 2020. The reasons for those final decisions can be read here: TGA caffeine verdict

Vitamin B6 Rules Change? Australia’s TGA Reviews Low-Dose Intake Link to Peripheral Neuropathy

Australian regulator, the TGA is reviewing recent reported cases of vitamin B6 intake and the possible side effect of peripheral neuropathy.   Source: (Copyright) Tingmin Koe, NutraIngredients Asia Vit B6 concerns  (Please see also TGA B6 safety advisory ) .

TGA Recall: Blackmores Professional Duo Celloids S.C.F. Tablets

Fit-BioCeuticals, in consultation with the TGA, is recalling all current batches of Blackmores Professional Duo Celloids S.C.F. tablets due to the potential for contamination with mould.   Source: Celloid recall

MMS Australia Fined $151,200 for Alleged Unlawful Advertising

The TGA has issued twelve infringement notices totalling $151,200 for the alleged unlawful advertising of Miracle Mineral Supplement (also referred to as Miracle Mineral Solution) (MMS) and other medicines by Southern Cross Directories Pty Ltd trading as MMS Australia. There is no clinical, scientifically-accepted evidence showing that MMS can cure or alleviate any disease. The use of MMS presents serious health risks, and can result in nausea, vomiting, diarrhoea and severe dehydration, which in some cases can result in hospitalisation. The TGA is monitoring non-compliance, particularly in relation to the advertising of products that claim to prevent or cure COVID-19 and will continue to take action in relation to any advertisements that do not meet the requirements.    Source: MMS massive fine   (Please also see further reading: Safety Advisory: MMS tabs )

The ‘Innovation Nation’ for Supplements: Australian Industry Hails Five-Year Protection for Clinical Trials

Industry leaders in Australia have hailed cross-party agreement that will lead to five years protection for clinical trials for complementary medicines and supplements, a world-first move that trade body Complementary Medicines Australia says will reward companies at the cutting edge of research.   Source: (Copyright) Gary Scattergood, NutraIngredients (Asia) Oz clinical trials

Artemisia annua Extract to Become Prescription-Only Medicine in New Zealand

New Zealand’s Ministry of Health has declared that Artemisia annua extract is now classified as a prescription medicine, following a recommendation from the Medicines Classification Committee (MCC). The new classification means it will no longer be able to be sold in pharmacies or online. This classification affects the artemisia annua extract only, not the plant. All products containing artemisia annua extract can now only be supplied on a prescription given by a health care professional authorised under the Medicines Act 1981. There are no approved products containing artemisia annua extract currently available in New Zealand.    Source: NZ artemesia extract ban   (Please also see NHPNZ response to this development: NHPNZ response to artemesia extract restriction ) (Editor note: This new classification does not affect its status in Australia and it is still permitted in complementary medicines)

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